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. 2014 Dec 8;2014(12):CD010590. doi: 10.1002/14651858.CD010590.pub2

TIVOLI Study 2013

Methods

  • Study design: RCT

  • Study duration: Participants screened between February 2008 and July 2009
Participants

  • Setting: multicentre

  • Country: Spain

  • Stage of CKD: CKD stage 3 and 4

  • Number: darbepoetin alfa (25), methoxy polyethylene glycol epoetin beta (46)

  • Median age; range (years): darbepoetin alfa (56; 52 to 66), methoxy polyethylene glycol epoetin beta (55.5; 47 to 63)

  • Sex (M/F): darbepoetin alfa (17/8), methoxy polyethylene glycol epoetin beta (19/27)

  • Other characteristics: Hb levels 10 to 12 g/dL; receiving maintenance darbepoetin alfa

  • Exclusion criteria: NS
Interventions Treatment group

  • Darbepoetin alfa

    • SC targeting Hb level 10 to 12 g/dL for 6 months


Control group

  • Methoxy polyethylene glycol epoetin beta

    • SC targeting Hb level 10 to 12 g/dL for 6 months


Iron supplementation

  • As required
Outcomes Primary study outcome

  • Maintaining average Hb concentrations within both ±1 g/dL of baseline and the range of 10 to 12 g/dL during the evaluation period


Outcomes extracted for meta‐analysis

  • All‐cause mortality

  • Transfusion

  • Hypertension
Notes

  • Funding: F. Hoffman‐La Roche

  • Trials registration: NCT00605345

  • Contact with authors: contacted (no reply or data received)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk Not described
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Not described
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not described
Incomplete outcome data (attrition bias) All outcomes Low risk 3/24 lost to follow‐up in darbepoetin arm (13%) and 1/46 lost to follow‐up in methoxy polyethylene glycol epoetin beta arm (2%). As this was <10% overall and differences between arms were not reliable due to small numbers of events, this was adjudicated as low risk
Selective reporting (reporting bias) High risk Data for cardiovascular events not available
Other bias High risk Published as letter only; writing supported and funded by sponsor